Metformin empagliflozin composition and preparation method thereof

Abstract

The invention discloses a metformin empagliflozin tablet and a preparation method thereof. The tablet is prepared from the following raw materials in parts by mass: 500 parts of metformin hydrochloride, 5 parts of empagliflozin, 30.13 parts of corn starch, 47.2 parts of povidone, 2.95 parts of colloidal silicon dioxide, 4.72 parts of magnesium stearate and 29.5 parts of a film coating premix. The preparation method comprises the following steps: crushing empagliflozin and sieving with a 80-mesh sieve, respectively sieving metformin hydrochloride and corn starch with a 40-mesh sieve, and sieving colloidal silicon dioxide with a 80-mesh sieve; mixing the metformin hydrochloride with the corn starch; fluidized bed granulation: a, copovidone is dissolved in purified water, empagliflozin is added, and a medicine-containing granulation solution is obtained; b, granulating; granulating the dried granules by using a 1.0-1.5 mm screen mesh; adding colloidal silicon dioxide and magnesium stearate according to the prescription amount, and mixing; tabletting, wherein the pressure is controlled to be 3.0 KN to 6.0 KN; and coating: controlling the weight gain of the coating to be 2.0-5.0%.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a metformin empagliflozin composition and a preparation method thereof. Background technique [0002] The incidence of type II diabetes is increasing, and its complications (such as diabetic foot, blindness, renal failure, etc.) not only affect the quality of life of patients, but also may lead to shortened life span. Empagliflozin is an oral sodium-glucose cotransporter-2 (SGLT-2) inhibitor. SGLT-2 is the transporter mainly responsible for the reabsorption of glucose from the glomerular filtrate into the systemic circulation. By inhibiting SGLT-2, empagliflozin reduces the renal reabsorption of filtered glucose and lowers the renal threshold of glucose, Thereby increasing the excretion of urinary sugar. Metformin hydrochloride is a classic hypoglycemic drug that can reduce fasting and postprandial hyperglycemia in patients with type II diabetes. [0003] Metformin Empaglif...

AI Technical Summary

Problems solved by technology

The preparation method adopts the process of dispersing Empagliflozin in the granulation liquid, and then performs fluidized bed granulation. By controlling the fluidized bed granulation parameters and granule moisture, the content of Metformin Empagliflozin Tablets prepared by the traditional process is mainly solved. Problems of poor uniformity, small tablet hardness, unqualified friability, and large dissolution RSD value at 15 minutes

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